Inspections, Compliance, Enforcement, and Criminal Investigations
Kettle Edge Dairy 05-Jan-04
Department of Health and Human Services
Public Health Service
Minneapolis District Office
January 5, 2004
RETURN RECEIPT REQUESTED
Refer to MIN 04 - 12
Joseph R. Hemauer
Kettle Edge Dairy
W7782 County Road N
Plymouth, Wisconsin 53703
Dear Mr. Hemauer:
On August 26, 2003, an investigator from the Food and Drug Administration (FDA) conducted an inspection at your dairy operation located in Plymouth, WI. That inspection confirmed that you offered a dairy cow for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(c)(ii) and (a)(4). You also caused the adulteration of a new animal drug because the drug was used in a manner that does not conform to its approved use or the extralabel use regulations at Title 21, Code of Federal Regulations, Part 530 (21 CFR 530, copy enclosed). This caused the new animal drug to be unsafe under Section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of Section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).
On or about June 29, 2003, you sold a cow, identified with back tag number 35HW4553, for slaughter as human food through [redacted]. The animal was sold to and slaughtered by [redacted]. Our inspection documented that you treated the animal with ampicillin, which is an antibiotic drug in the penicillin family. United States Department of Agriculture (USDA) analysis of tissue samples collected from that animal identified the presence of 0.21 ppm penicillin in the kidney. The USDA analysis currently does not distinguish among the antibiotic drugs in the penicillin family. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle (21 CFR 556.510, copy enclosed). A tolerance of 0.01 ppm has been established for residues of ampicillin in the uncooked edible tissues of cattle (21 CFR 556.40, copy enclosed). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).
Our investigation also found that you hold animals under conditions that are inadequate to prevent animals bearing potentially harmful drug residues from entering the food supply. For example, you do not maintain medication records to avoid unsafe residues. You also lack an adequate system for assuring that drugs are not used in a manner contrary to the labeled directions and for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).
You also adulterated ampicillin within the meaning of Section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5), when you failed to use the drug in conformance with the approved conditions of use or the extralabel use regulations at 21 CFR Part 530. Because your use of ampicillin was outside of the approved conditions of use and not on the order of a licensed veterinarian, your use of the drug was not in compliance with extralabel use regulations, in particular 2 1 CFR 530.10 and 530.11(a). As a result, your use of this new animal drug caused it to be unsafe under Section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of Section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your operations and the foods you distribute are in compliance with the law.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not occur. Failure to do so may result in regulatory action (such as seizure or injunction) without further notice to you.
It is not necessary for you to personally ship an adulterated animal in interstate commerce to be held responsible for a violation of the Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act. You should notify this office in writing within 15 working days of receipt of this letter of the steps you have taken to bring your dairy operation into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation that corrections have been made.
Your reply should be directed to Compliance Officer Brian D. Garthwaite, Ph.D. at the address indicated on the letterhead.
W. Charles Becoat